Recruiting

Observational Study

Sponsor:

Jorvec Corp.

Code:

NCT06388096

Conditions

Glaucoma, Suspect

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

Pattern Electroretinogram

Study Details

Brief summary:

Glaucoma is a progressive disease resulting in blindness. Determining the onset of the disease is critical so patients may obtain treatment to preserve useful vision. This study will collect data from a population of glaucoma suspects (with positive factors for the disease but with normal vision) along with a population of age matched controls using the pattern electroretinogram (PERG) and other standard eye tests for glaucoma. The PERG measures the function of retinal ganglion cells (RGCs) which come together to form the optic nerve. RGCs may become dysfunctional before dying. The Continuous loop deconvolution technique (CLAD) will be used to extract transient PERG responses in both glaucoma suspects and age matched controls. All patients will be monitored with PERG, Optic Coherence Tomography (OCT) and other ancillary tests over 2 years. CLAD will be compared with conventional techniques of monitoring glaucoma (standard PERG, OCT, visual field etc) to see if the CLAD is better at distinguishing between glaucoma suspects and controls.

Conditions

Glaucoma, Suspect

Study ID

NCT06388096

Start date

Jun 1, 2023

Status verified date

May, 2024

Completion date

Jun 1, 2025

Anticipated

Primary completion date

Jun 1, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Inclusion Criteria:

1. Age 18 to 85 years, inclusive
2. Refractive errors within -5 to +3 diopters
3. Best corrected visual acuity (BCVA) better than or equal to 20/30 (Snellen)
4. Normal standard automated perimetry (SAP) according to the Ocular Hypertension Treatment Study (OHTS) criteria15 (reliability < 15% on all indices, normality > 5% on all global indices in two consecutive sessions 6 months apart)
5. Minimum untreated Intraocular pressure IOP of 15 mm Hg
6. Glaucoma Suspect Status defined as one or more of the following:

  • Glaucomatous optic disc appearance (vertical cup-to-disc ratio \[C/D\] ≥0.5
  • Cup disc ratio asymmetry ≥0.2
  • Localized thinning of the disc
  • Presence or history of splinter disc hemorrhage
  • Moderately increased IOP (>21 to <28 mm Hg).
  • Family history of vision loss for glaucoma

Exclusion Criteria:

1. Age-related macular degeneration
2. Diabetes
3. Parkinson's disease
4. Multiple sclerosis
5. Unwilling or unable to give consent, unwilling to accept randomization, or unable to return for scheduled protocol visits.
6. Pregnant or nursing women.
7. Currently using prescribed pressure lowering medicines and unwilling to be withdrawn from them.
8. An OHTS risk score high enough in the judgment of the ophthalmologist or optometrist managing the patient to recommend pressure lowering medicine to the patient and not randomization.
9. An OCT abnormal enough in a pattern consistent with glaucoma.

Study Design

Enrollment

120 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Device Feasibility

Interventions and Outcome Measures

Arms

experimental: Glaucoma Suspects

Patients with suspicion of glaucoma based on positive factors of disease.

active comparator: Controls

Age matched controls to the glaucoma suspect group with no indications of glaucoma.

Interventions

Pattern Electroretinogram

Non-invasive recording of retinal potentials from a modulating pattern stimulus viewed on a visual display and recorded from surface electrodes around the eye.

Primary outcome measure

  • PERG Amplitude [ Time Frame: Immediately after measurement ]
  • PERG Latency [ Time Frame: Immediately after measurement ]

Central Contacts and Locations

Central contacts

Jonathon A Toft-Nielsen, PhD

305-668-6102jtoftnielsen@jorvec.com

Edward Miskiel, PhD

305-688-6102emiskiel@jorvec.com

Locations

University of Miami, Bascom Palmer Eye Institute 900 NW 17th Street

Recruiting

Miami, Florida, United States, 33136

Contacts

Vittorio Porciatti, MD/PhD

vporciatti@med.miami.edu

More Information

Sponsor

Jorvec Corp.

Last update posted

May 16, 2024

Last verified

May, 2024

Keywords

  • Glaucoma

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Jorvec Corp. on 2024-05-16.